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Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT03147963
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Huang Ping, Zhejiang Cancer Hospital

Brief Summary:
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Phase 2

Detailed Description:
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-weeks Regimen
Actual Study Start Date : December 20, 2015
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Docetaxel 2-Weeks regimen group
Docetaxel injection 50mg/m2,iv,d1,every 2 weeks
Drug: Docetaxel
Docetaxel will be given until progression or patient intolerance

Active Comparator: Docetaxel 3-Weeks regimen group
Docetaxel injection 75mg/m2,iv,d1,every 3 weeks
Drug: Docetaxel
Docetaxel will be given until progression or patient intolerance




Primary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years ]
    Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause


Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: From date of enrolling until the date of death from any cause, assessed up to 5 years ]
    The time elapsed between enrolling and death from any cause

  2. Clinical benefit rate(CBR) [ Time Frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years ]
    The response is CR+PR+SD ≥ 24 weeks

  3. Quality of life(QOL) [ Time Frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years ]
    Score change from enrolling to progression disease or death according EORTC QLQ-C30.The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.

  4. Number of participants with Grade 3/4 adverse events [ Time Frame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years ]
    Number of participants with Grade 3/4 adverse events of the two groups was assessed in accordance with the common terminology criteria (NCI CTC AE) version 4.0.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • The age is Above 18 years of age, <70 years old
  • The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative
  • Clinical stage was metastatic breast cancer or locally advanced breast cancer.
  • Must have at least one measurable lesion, according to RECISTv1.1.
  • Eastern Cooperative Oncology Group performance status (ECOG PS)=0~2
  • Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months.
  • The basic function of normal bone marrow
  • Functions of liver and kidney is normal
  • Expectation of life is more than 3 months
  • Agreed to take contraceptive measures during treatment

Exclusion Criteria:

  • The patient had a history of allergy to taxanes or their components.
  • Recent progress of taxanes in 6 months.
  • In the elution period of other chemotherapy regimens.
  • Severe coagulopathy.
  • HER2 positive breast cancer
  • Previous toxicity was not recovered to 0-1 degrees
  • Central nervous system metastasis had not Controlled yet
  • Pregnancy or lactation
  • There are uncontrolled infection, myocardial infarction, thrombosis, etc.
  • There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
  • HIV infection
  • Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
  • Researchers believe that is not suitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147963


Contacts
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Contact: Xiaojia WANG, MD,PHD 8613906500190 wxiaojia0803@163.com
Contact: Ping HUANG, MD 8613685766632 zlyyhp@163.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaojia WANG, MD,PhD    +86 13906500190    wxiaojia0803@163.com   
Contact: Ping HUANG, MD    +86 13685766632    zlyyhp@163.com   
Principal Investigator: Xiaojia WANG, MD,PhD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Xiaojia WANG, MD,PHD Zhejiang Cance Hospital

Publications:
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Responsible Party: Huang Ping, attending doctor, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03147963     History of Changes
Other Study ID Numbers: ZCHBC0011
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huang Ping, Zhejiang Cancer Hospital:
therapy
breast cancer
docetaxel
metastasis
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action